Chemicals and Fertilizers minister Ram Vilas Paswan has countered the claims made by the drug industry that the National Pharmaceutical Policy 2006 proposed by him would result in across the board increase in the span of price control on drugs. The minister said that the increase in the span of price control would be just 8 per cent that of the existing percentage of price controlled medicines. The total drugs that would come under price control as per the proposed policy would be 33 per cent of the entire drugs marketed in the country, he explained.

Addressing a press conference to clarify the official position on the proposed pharma policy here today, Paswan said that the industry should stop pursuing their narrow goals and accept the policy proposal in a larger national interest. According to him, the current proposal was the only option before the government as it had to abide by the Supreme Court Order to incorporate all essential medicines under price control category. "The thrust of price control in the current policy is on monopoly drugs. It has changed in the proposed policy and the thrust is to bring only essential drugs under price control. The government has also proposed a higher Maximum Allowed Post Manufacturing Expense (MAPE) to help the drug industry, "Paswan explained.

Asked to react on the negative comments given by several other ministries on the draft proposal, Paswan said that his ministry was free to amend the DPCO without consulting any other ministry. "However, we are trying to get the feedback from all concerned ministries before finalizing the policy", he added.

Our Mumbai Bureau adds:

Three Ministries opposing Pharma Policy in present form

At least three key ministries are opposing implementation of certain provisions in the proposed Pharmaceutical Policy 2006 in the present form, it is learnt.

Senior industry sources told Pharmabiz on the sidelines of a CII press conference on the proposed National Pharmaceutical Policy that the Ministry of Health, the Ministry of Science & Technology and the Ministry of Industries have informed the Chemical Ministry their dissent on certain provisions of the policy. Further, the pharmaceutical industry associations are unitedly opposing the policy. "With this kind of opposition, it is impossible to implement this Policy in the present form, especially the provisions on increasing span of price control," they noted.

The draft policy is currently in circulation with the various related ministries for their comments and suggestions, as prelude to Cabinet approval and PMO's vetting to move to the Parliament for legislation.

As reported, the Union health Ministry had cautioned against increasing the span of control in the new Policy as it may lead to companies discontinuing the production of such drugs. It also felt that the proposal to consider a company of having "R&D Gold Standard" by looking into the approvals its drug manufacturing facilities has from international drug regulatory agencies is not appropriate.

Echoing similar sentiments, CII said in a press conference in Mumbai that any sudden regulatory shocks like increased price control would be detrimental to the industry.

Expanding price control could lead to discontinuation of production of some unviable drugs and in the long run, investment in R&D could be affected. Indian pharma industry would be forced to cut down its 1.5 lakh medical reps thus affecting employment generation. Introduction of new drugs could be delayed and the drugs would still be priced high, said Ajay Piramal, chairman, National Committee on Drugs & Pharmaceuticals, CII.

He said a way forward is to freeze the price control and maintain status quo with current 74 drugs. Instead of expanding the span, effective regular monitoring of NLEM drugs could regulate abnormal price increase. Government agencies should be allowed to voluntarily procure drugs at a ceiling price of 50 per cent of MRP. Effective regulation of trade margins could ensure patients get full benefits from generic products. Instead of the Gold Standard provision, the Government should provide adequate differentiated incentives for R&D oriented Indian companies. The current price control regime has worked well as prices are not increasing, said Ajay Piramal.